Kornimate/medical-research-clean huggingface dataset:
precision-panc master protocol: personalising treatment for pancreatic cancer

Conditions: Neoplasms Pancreatic

Summary: the precision-panc master protocol is a "portal" protocol for patients with known or suspected pancreatic cancer to be accrued through multiple centres in the uk, with the option of being subsequently enrolled into primus (pancreatic cancer individualised multi-arm umbrella studies) examining different treatment regimens and/or biomarker development. eligible patients will undergo tumour biopsy and blood collection prospectively for molecular profiling at a central laboratory and the results may be used to inform enrolment to primus studies.


Eligibility criteria:
inclusion criteria: * adult patients (age \>16 years). * either: * presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a pancreatic multi-disciplinary team (mdt). or o histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants. * patient is willing and able to undergo additional tumour biopsy (from the primary or a metastatic site) aimed at obtaining sufficient tissue for molecular profiling if this is required. * patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation. * patient is deemed potentially eligible for a currently open primus study * patient has signed informed consent for screening research tumour biopsy (consent 1). * patient has signed informed consent for precision-panc master protocol molecular profiling (consent 2).
permissive hypercapnia during one lung ventilation: impact on right ventricular systolic and diastolic functions during lung resection

Conditions: Anesthesia

Summary: investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. initial tidal volume (vt) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (olv) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (paco2) 30-35 mm hg. data were obtained at: t1, 15 min post establishing olv with normocapnia, t2, 15 min post establishing olv with hypercapnia (paco2 7.98kpa (60mmhg) and 9.31kpa (70mmhg) and ph \>7.1), and t3, 15 min after resuming olv with normocapnia. one-way repeated measures analysis of variance (anova), with post hoc dunnet´s test were used for analysis. a p value \< 0.05 is considered statistically significant.

investigators studied 15 patients scheduled for elective pulmonary resection through thoracotomy. patients had a standardized management for thoracotomies. initial vt 10ml/ kg was reduced to 8ml/kg after olv and the rate adjusted to maintain paco2 30-35 mm hg. haemodynamic, respiratory variables and echocardiographic data (tei index and tapse) were obtained at: t1, 15 min post establishing olv with normocapnia, t2, 15 min post establishing olv with hypercapnia (paco2 7.98kpa (60mmhg) and 9.31kpa (70mmhg) and ph \>7.1), and t3, 15 min after resuming olv with normocapnia. one-way repeated measures anova, with post hoc dunnet´s test were used for analysis. a p value \< 0.05 is considered statistically significant.

Eligibility criteria:
inclusion criteria: * adult \>18 yr * elective pulmonary resection through thoracotomy. exclusion criteria: * patients with pulmonary hypertension (systolic \>50mmhg), * intracranial hypertension or previous intracranial haemorrhage, * pre-existing hypercapnia, * co-existing metabolic acidosis, * ischaemic heart disease, * predicted postoperative fev1\<800 ml or \<40% of the expected in pneumonectomy * patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.
optimal number of hyperbaric oxygen treatments for carbon monoxide poisoning

Conditions: Hyperbaric Oxygen Therapy; Carbon Monoxide Poisoning

Summary: the optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. initial landmark studies showed a decrease in the incidence of dns with a single treatment and also with three treatments over the course of 24 hours. these two strategies have continued to be used widely without further evidence comparing them in a direct fashion. retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. the investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.

hbo is a niche treatment modality, especially in canada. there are few sites which offer this care, and as such, treatment often carries significant logistical challenges. since 2021, the hbo unit at the misericordia hospital has averaged 49 patients per year being treated for co poisoning. this hbo unit provides coverage to patients within alberta, saskatchewan, manitoba, yukon, and northwest territories. due to the significant barriers to treatment, including the high cost to the public system, it is important to clearly understand how to best treat these patients. purpose: the aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning.

Eligibility criteria:
inclusion criteria: * all adult (over 17 years old) patients referred to a hyperbaric unit for acute carbon monoxide poisoning. exclusion criteria: * obtunded * mechanically ventilated * pregnant * incarcerated * cognitively impaired (acutely or chronically)
analgesic potentials of preoperative pregabalin,magnesium sulphate and their combination in acute post-thoracotomy pain

Conditions: Postoperative Pain

Summary: this study evaluates the effect of giving preoperative adjuvant drug as pregabalin or magnesium sulphate or a combination of both drugs to decrease postoperative morphine consumption and pain intensity in the first 24 hours in postoperative period . quarter of patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter receive single intravenous magnesium sulphate 50mg per kg over 200ml saline over 20 minutes preoperatively , other quarter receive combination of both drugs , the last quarter receive placebo drugs . all patients receive 0.1mg per kg intravenous morphine sulphate intraoperatively

magnesium (mg) acts on n-methyl-d-aspartate (nmda) receptor as a non-competitive antagonist with antinociceptive effects. gabapentin is an alkylated analogue of gammaaminobutyric acid (gaba) developed primarily as an anticonvulsant drug. it was described as an analgesic drug for the treatment of neuropathic pain in the 1990s. although it is named gabapentin,it does not bind at the gaba a or gaba b receptor. it binds with high affinity for the α2δ subunit of the presynaptic voltage-gated calcium channels, which reduce calcium-dependent release of pro-nociceptive neurotransmitters in the pain pathways. pregabalin is a structural analogue of gaba was introduced after gabapentin. if we used these drugs in combination to opioids preoperatively as preventive analgesia may decrease postoperative opioid consumption and pain intensity.

Eligibility criteria:
inclusion criteria: 1. asa status of1 or 2 2. patients undergoing thoracotomy 3. body mass index (bmi): less than forty and more than twenty. exclusion criteria: - 1. known sensitivity or contraindication to drugs used in the study. 2. history of psychological disorders and/or chronic pain. 3. patients receiving medical therapies that are considered to result in tolerance to opioids. 4. significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.
a randomized comparison study of aquacel ag and glucan ii as donor site dressings

Conditions: Burns

Summary: the research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, glucan ii and aquacel ag.


Eligibility criteria:
inclusion criteria: * adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting exclusion criteria: * individuals under the age of 18.

Keywords: burn injury skin graft donor site dressing outcomes infection rate healing time cosmetic result pain burn injured patients requiring skin grafting
structural and functional connectivity of brainstem monoamine pathways in treatment resistant depression

Conditions: Treatment Resistant Depression

Summary: study trd subjects' resistance to at least 2 different antidepressants, we hypothesize that because of their significant depression and treatment resistant status they are most likely to exhibit bsmn pathway abnormalities.

potential subjects will be identified during clinical visits. if a patient qualifies to participate in the study they will have to stop any antidepressants that they are taking to prepare for the use of maois. after a two week washout period, subjects will have an fmri and will be started on a maoi. they will then be followed up for 8 weeks, which is routine and considered standard care.

Eligibility criteria:
inclusion criteria - trd: 1. age: 18 - 65 yrs.; 2. satisfy criteria for dsm-iv major depressive disorder (mdd); 3. 17-item hamilton depression rating scale (17-item hdrs) score \> 18; 4. treatment resistance depression as defined as report of inadequate response (patient report of minimal improvement or nonresponse) despite past treatment with at least 2 different classes of antidepressants acting on the 5-ht and/or da monoamine systems(except maois) (as determined with the antidepressant treatment history form (athf)20 with score of \>3 on each of the items and verified by medical records if available); 5. able to give informed consent; 6. no use of alcohol in the past 1 week and negative urine toxicology screen; 7. maoi treatment indicated as assessed by an independent psychiatrist not affiliated with the study; 8. voluntary consent to treatment with an maoi after reviewing all other options and agree to follow safeguards and precautions during treatment. inclusion criteria for healthy subjects 1. ages 18-65 years and ability to give voluntary informed consent; 2. no history of psychiatric illness or substance abuse or dependence; 3. no significant family history of psychiatric or neurological illness; 4. not currently taking any prescription or centrally acting medications; no use of alcohol in the past 1 week; 5. and no serious medical or neurological illness. exclusion criteria - trd: 1. schizophrenia, schizoaffective or primary anxiety disorder; 2. serious medical or neurological illness; 3. history of significant head injury; 4. on fluoxetine treatment; 5. on lithium or have received ect or rtms in the last 3 months to avoid long-term effects of such medications; 6. substance or alcohol dependence in the past 6 months or substance abuse in the past 3 months; 7. unable to give informed consent. exclusion criteria for both groups: 1. pregnant or breast-feeding; 2. metallic implants or other contraindication to mri.

Keywords: treatment resistant depression
bicentric clinical investigation to assess safety and performance of luxhighadd iol

Conditions: Cataract

Summary: the study purpose is to demonstrate safety and performance of bilateral implantation of luxhighadd intraocular lens compared with the luxgood monofocal lens.

the study purpose is to demonstrate safety and performance after bilateral implantation of luxhighadd intraocular lenses. the device under investigation is a hydrophobic acrylic multifocal intraocular lens (iol) manufactured by the sponsor of this study.

Eligibility criteria:
inclusion criteria: * subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation * no ocular comorbidity possibly affecting the study results * fit within the available iol diopter range * have had no previous refractive surgery * regular corneal astigmatism ≤1.0 dioptres * clear intraocular media other than cataract * availability, willingness and sufficient cognitive awareness to comply with examination procedures * ability to attend all study follow-ups * signed informed consent. exclusion criteria: * ocular surface disease potentially affecting study results * pre-existing ocular pathology or history of pathology potentially affecting the study results * acute or chronic disease or illness that would increase risk or confound study results * subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than yag capsulotomy) * axial lengths and keratometry such as the iol spherical power is not in the range of 16 to 26 d * instability of keratometry or biometry measurements * traumatic cataract * amblyopia * history of ocular trauma or any prior ocular surgery including refractive procedures * capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens * pupil abnormalities * systemic or ocular medication that could modify pupil dynamics * expected complicated surgery or complicated surgery * concurrent participation in another drug or device investigation
next-generation effects of vitamin d supplementation in pregnancy

Conditions: Growth; Vitamin D Supplementation; Immune System Diseases; Child Development

Summary: vitamin d deficiency is common among pregnant women, despite daily vitamin d supplements. this study aims to investigate if maternal vitamin d intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. blood samples at birth and after one year, questionnaires and clinical 1-year examination will be performed on the children.

vitamin d deficiency is common among danish pregnant women, although most pregnant women adhere to guidelines of a daily supplement of 10 µg vitamin d. vitamin d deficiency increases the risk of complications in the pregnancy e.g., preeclampsia, gestational diabetes mellitus and fetal growth retardation. several studies indicate that the offspring has an increased risk of immune diseases e.g., asthma and autoimmune related diseases e.g., multiple sclerosis if the mother had vitamin d deficiency during the pregnancy. it is well known that vitamin d affects the immune system, which raises the question of the effects of vitamin d supplements and which doses to give optimally. this study aims to investigate if maternal vitamin d intake of 90 vs 10 µg d3 affects the overall health, growth, and immune system of the offspring at birth and after 1 year. blood samples at birth and after 1 year, questionnaires and clinical 1-year examination will be performed on the children. the hypothesis is that increased vitamin d supplementation in pregnancy improves fetal development including the offspring's immune system and the developing brain. the effects of vitamin d supplementation will strengthen the offspring's overall health at birth and during their first year of life. hopefully, this can, in the future, be part of a guideline to which dose of vitamin d is recommended for danish pregnant women.

Eligibility criteria:
inclusion criteria: * born by mother from our previous rct (nct04291313) * all with parental authority have given consent for inclusion exclusion criteria: * mother with compliance \<80% to study drug * mother has denied further contact in this follow-up study
the effect of tdcs based on functional brain imaging for subacute stroke patients

Conditions: Stroke

Summary: the purpose of this study is to investigate whether brain imaging-based hand function area tdcs stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.


Eligibility criteria:
inclusion criteria: * unilateral stroke patients aged 19 to 80 years * patients with subacute stroke within 4 weeks of onset * patients with moderate or severe upper extremity dysfunction with an upper extremity fma score of less than 58 in motor function evaluation exclusion criteria: * accompanied by an existing serious neurogenic disease * existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia. * if there are difficulties in conducting the research * any patients who are judged by the investigator to be difficult to participate in this study * exclusion criteria for transcranial direct current stimulation: i) patients with implanted medical devices in the body (e.g. pacemakers) ii) when a metal object is inserted in the skull iii) if there is a wound on the skin of the attachment site iv) history of epilepsy v) pregnant and lactating women
a study of trimetrexate plus leucovorin in children with pneumocystis carinii pneumonia

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with pneumocystis carinii pneumonia (pcp) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., tmp/smx or parenteral pentamidine).

patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. patients are followed for 1 month.

Eligibility criteria:
inclusion criteria patients must have: * pneumocystis carinii pneumonia (pcp) confirmed within 15 days prior to study entry. * serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of pcp, or a documented history of such intolerance during a prior episode. exclusion criteria patients with the following prior conditions are excluded: history of type i hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.

Keywords: trimetrexate pneumonia, pneumocystis carinii leucovorin drug therapy, combination acquired immunodeficiency syndrome
phase 4 gastrointestinal tolerability study of dimethyl fumarate in patients with relapsing forms of multiple sclerosis in the united states

Conditions: Relapsing Forms of Multiple Sclerosis

Summary: the primary objective of this study is to evaluate the effect of symptomatic therapies on gastrointestinal (gi)-related events reported by participants with relapsing forms of multiple sclerosis (ms) initiating therapy with dimethyl fumarate (dmf) in the clinical practice setting. the secondary objectives of this study are as follows: * to evaluate gi-related events requiring symptomatic therapy and the role of those therapies over time in participants with relapsing forms of ms initiating therapy with dmf in the clinical practice setting. * to evaluate gi-related events that lead to dmf discontinuation after the use of symptomatic therapy in participants with relapsing forms of ms initiating therapy with dmf in the clinical practice setting.


Eligibility criteria:
key inclusion criteria: * decision to treat with dmf must precede enrollment. * naïve to dmf or fumaric acid esters. * resides in the us and has a confirmed diagnosis of a relapsing form of ms. * satisfies the approved therapeutic indication(s) for dmf. key exclusion criteria: * inability to comply with study requirements or, at the discretion of the investigator, is deemed unsuitable for study participation. * history of significant gi disease, chronic use of gi symptomatic therapy, active malignancies. * is participating in any other interventional clinical trial. note: other protocol-defined inclusion/exclusion criteria may apply.
reduced dose of prophylactic dexamethasone for elderly patients receiving moderate emetogenic chemotherapy

Conditions: Colonic Neoplasms

Summary: feasibility study to evaluate the efficacy of reduced prophylactic dose of dexamethasone in elderly patients receiving moderate emetogenic chemotherapy

the purpose of this trial is to determine if the dose of dexamethasone used as an antiemetic drug in patients with advanced cancer could be safely reduced.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed colorectal cancer patients with curative resection * ecog performance status 0-2 * provision of signed, written and dated informed consent prior to any study specific procedures * receiving adjuvant chemotherapy with folfox (5-fu, leucovorin, oxaliplatin) regimen exclusion criteria: * having contraindication to dexamethasone * having nausea or vomiting before the start of adjuvant chemotherapy
the effect of donepezil on gait and balance in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study involves parkinson's disease (pd). symptoms include slow movement, tremor, and muscle rigidity. current medications for the treatment of pd do not improve gait and balance difficulties in individuals with pd. donepezil (study drug) has been found to reduce falls in individuals with pd. the mechanism in which this reduction of falls occurs is unclear. the investigators study will look at what aspects of gait and balance are improved by the study drug. the study drug is not approved to treat pd in the united states or other countries because we do not know enough about it.

parkinson's disease (pd) is a common neuro-degenerative disease affecting about 2% of the adult population in the united states over the age of 65. some of the most disabling symptoms of parkinson's disease are balance and gait dysfunction, leading to falls. these symptoms do not respond to current dopamine directed therapies. evidence from both pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in the thalamus and basal ganglia is found in individuals with pd who fall compared to non-fallers. the central acting acetylcholine esterase inhibitor, donepezil, has been demonstrated to decrease falls in individuals with pd. the mechanism by which falls decreased is unknown. our open label pilot data indicates that donepezil can improve quantitative measures of balance in individuals with pd. suggesting that improvements in balance in the mechanism by which donepezil reduces falls. our goal is to determine whether donepezil will: * improve quantitative measures of balance in subjects with parkinson's disease compared to placebo. * improve quantitative measures of gait in subjects with parkinson's disease compared to placebo. * improve cognitive measures in non-demented subjects with parkinson's disease.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease, defined by the uk brain bank criteria, with a hoehn and yahr score of 2 to 4 * treated with levodopa for at least a year and on a stable antiparkinsonian regimen for at least one month * abnormal computerized dynamic posturography (cdp) on screening defined as a composite score below 65 (range 1-100) exclusion criteria: * dementia defined by mmse less than 27 * other medical conditions other than pd affecting balance or gait as determined by the investigators * unable to stand unassisted for 30 minutes * current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic properties * medical or psychiatric co-morbidities that may interfere with compliance or might place subject in danger as determined by the investigators

Keywords: donepezil parkinson's disease balance cholinesterase inhibitor